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The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03478449
Recruitment Status : Active, not recruiting
First Posted : March 27, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Study Description
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Brief Summary:
The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.

Condition or disease Intervention/treatment Phase
Lymph Node Metastases Gastric Cancer Exanimation Procedure: lymph node sorting for pathological examination Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : November 2, 2020
Estimated Study Completion Date : December 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fine sorting lymph node group Procedure: lymph node sorting for pathological examination
In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.
No Intervention: Regional sorting lymph node group


Outcome Measures
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Primary Outcome Measures :
  1. Migration of pN stage in gastric cancer patients [ Time Frame: 60 months ]
    According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Physical conditions compliance with the requirements for curative gastrectomy
  • 2) Consent to undergo the D2 lymphadenectomy
  • 3) Comply with the protocol during the whole study period
  • 4) No neoadjuvant therapy administration
  • 5) Sign informed consent and permission of withdraw in the whole study period
  • 6) Consent to provide the tissue specimens after surgery for this study
  • 7) Pathological examination confirmation the adenocarcinoma of stomach before surgery
  • 8) Estimation the overall survival after surgery no less than 6 months
  • 9) No anesthesia or operation contraindication disease
  • 10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
  • 11) Negative cytological detection in operation
  • 12) No seriously concomitance's diseases
  • 13) Karnofsky Performance Scores (KPS) more than 60

Exclusion Criteria:

  • 1) Women during pregnant stage and breast-feed stage
  • 2) Women of childbearing age without any contraceptive measures
  • 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
  • 4) Immunosuppressive therapists for organ transplantation
  • 5) Seriously uncontrolled recurrent infection
  • 6) other malignant tumors
  • 7) No abilities of self-knowledge or mental disorders
  • 8) Participating in other clinical trials
  • 9) Siewert I and II esophagogastric junction tumors
  • 10) Serious internal diseases obstruction surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478449


Locations
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China
Cancer Hospital of Tianjin Medical University
Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
  Study Documents (Full-Text)

Documents provided by Tianjin Medical University Cancer Institute and Hospital:
Study Protocol  [PDF] February 1, 2018
Statistical Analysis Plan  [PDF] February 1, 2018
Informed Consent Form  [PDF] February 1, 2018

More Information
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03478449    
Other Study ID Numbers: DJY001
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases